Toradol

"The US Food and Drug Administration (FDA) has approved diclofenac sodium injection (Dyloject, Hospira Inc), a proprietary nonsteroidal anti-inflammatory drug (NSAID) for the treatment of mild to moderate pain, and for the management of mod"...

For Patients

Toradol (ketorolac tromethamine) is a nonsteroidal anti-inflammatory drug (NSAID) that is used to treat moderately severe pain and inflammation, usually after surgery. Toradol is available as a generic drug called ketorolac. Toradol works by blocking the production of prostaglandins, compounds that cause pain, fever, and inflammation. Some common side effects of Toradol include headache, heartburn, upset stomach, nausea or vomiting, diarrhea, stomach pain, bloating, gas, constipation, dizziness, drowsiness, sweating, and ringing in the ears.

Toradol is available as a 10 mg tablet and a solution (30 mg per ml) for intravenous (IV) or intramuscular (IM) administration. Toradol solution is administered as a single 15- to 60-mg dose once every 6 hours not to exceed 60 or 120 mg a day. The recommended oral dose is one to two Toradol tablets initially followed by one tablet every 4-6 hours, not to exceed 40 mg daily. Toradol should not be used for more than 5 days. Drug interactions may occur with lithium, ACE inhibitors, warfarin, and medications used to treat high uric acid levels. Warnings may apply to individuals who have ulcers, cardiovascular disease, kidney disease, and bleeding disorders. People who are taking aspirin or NSAIDs should not take Toradol because of the cumulative risk of inducing serious NSAID-related side effects. Toradol is generally avoided during pregnancy. Pregnant women may take Toradol only if it is clearly needed and the potential benefit justifies the potential risk to the fetus. Nursing mothers should not take Toradol, because it is excreted in breast milk. Toradol solution may be used as a single dose in children in certain instances, but safety and effectiveness in the pediatric population is not established.

Our Toradol Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Upset stomach, nausea, vomiting, constipation, diarrhea, gas, dizziness, or drowsiness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

SIDE EFFECTS

Adverse reaction rates increase with higher doses of TORADOL (ketorolac tromethamine) . Practitioners
should be alert for the severe complications of treatment with TORADOL (ketorolac tromethamine) , such
as GI ulceration, bleeding and perforation, postoperative bleeding, acute renal
failure, anaphylactic and anaphylactoid reactions and liver failure (see BOXED
WARNING, WARNINGS, PRECAUTIONS,
and DOSAGE AND ADMINISTRATION). These NSAID-related
complications can be serious in certain patients for whom TORADOL (ketorolac tromethamine) is indicated,
especially when the drug is used inappropriately.

In patients taking TORADOL (ketorolac tromethamine) or other NSAIDs in clinical trials, the most frequently
reported adverse experiences in approximately 1% to 10% of patients are:

Postmarketing Surveillance Study

A large postmarketing observational, nonrandomized study, involving approximately
10,000 patients receiving ketorolac tromethamineIV/IM, demonstrated
that the risk of clinically serious gastrointestinal (GI) bleeding was dose-dependent
(see Tables 3A and 3B). This was particularly true in elderly patients who received
an average daily dose greater than 60 mg/day of ketorolac tromethamineIV/IM
(see Table 3A).

Table 3 Incidence of Clinically Serious GI Bleeding as Related
to Age, Total Daily Dose, and History of GI Perforation, Ulcer, Bleeding (PUB)
After up to 5 Days of Treatment With Ketorolac TromethamineIV/IMA.